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U.S. Department of Health and Human Services

Class 3 Device Recall Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps

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  Class 3 Device Recall Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps see related information
Date Initiated by Firm December 17, 2012
Date Posted February 17, 2013
Recall Status1 Terminated 3 on December 24, 2013
Recall Number Z-0836-2013
Recall Event ID 64307
510(K)Number K042873  K032257  
Product Classification Pump, infusion, insulin - Product Code LZG
Product Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps
Indicated for continuous subcutaneous infusion of insulin.
Code Information All Animas 2020, IR1250 and IR1200 Pump Models - Part Numbers 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, 100385-00, 100450-00, 100210-00, 100211-00, 100212-00, 100250-00, 100251-00, 100252-00, 100200-00, 100201-00, 100202-00, 100170-00, 100171-00 and 100172-00.
Recalling Firm/
Manufacturer		 Animas Corporation
200 Lawrence Dr
West Chester PA 19380-3428
For Additional Information Contact
610-644-8900
Manufacturer Reason
for Recall		 Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display.
FDA Determined
Cause 2		 Device Design
Action The firm initiated their recall of this product on December 17, 2012 by sending a letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Animas Customer Support Department at (866) 796-6373 for questions or concerns.
Quantity in Commerce 37,998
Distribution Worldwide Distribution-USA (nationwide) including Washington, DC, Puerto Rico, US Virgin Island and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Austria, Australia, Bermuda, Canada, New Zealand, Czech Republic, Italy, France, Finland, Hungary, Israel, United Kingdom, Spain, Sweden, Norway, Denmark, Germany, Mexico and Ireland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = ANIMAS CORP.
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